08/20/2014

Failure to comply with the investigational plan / protocol.Failure to maintain case histories (source and CRFs).

So, lessons learned questions:

How could this have been prevented? From a sponsor's perspective was this a risky site? Did the risk assessment identify this as a potential risk and did the monitoring plan support risk mitigation at the site level?

What are the root causes?

What would have been an adequate corrective and preventive action plan from the investigator? The FDA stated twice "your response is inadequate..."